Phase I clinical study of brentuximab vedotin(SGN-35) involving children with recurrent or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large cell lymphoma (physician-led clinical study)
- Conditions
- Patients with recurrent or refractory CD30-positive HL or sALC
- Registration Number
- JPRN-jRCT1091220229
- Lead Sponsor
- ational Hospital Organization Nagoya Medical Center Keizo Horibe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
1) Asian patients aged 2 to 17 years on obtaining informed consent.
2) Those definitively diagnosed with CD30-positive HL or sALCL based on histological findings. A report or its copy describing that a specimen collected at the time of initial diagnosis or relapse was evaluated as positive for CD30 using an immunohistochemical procedure or flow cytometry is stored in the hospital.
3) Those with PD during standard chemotherapy or without CR/PR after treatment, or those with relapse or additional exacerbation after standard chemotherapy.
4) Those with an ECOG performance status (PS) of 0 to 2.
5) Those whose laboratory data on screening meet the following criteria. The administration of a gene recombinant human granulocyte-colony stimulating factor (G-CSF) preparation or blood transfusion is not performed within1 week before neutrophil and platelet count tests:
-Neutrophil count: >= 1,500/microL
-Platelet count: >= 75,000/microL
-Hemoglobin level: >= 8 g/dL
-Serum bilirubin level: <= 1.5-fold the upper limit of the normal (ULN) in the facility
-Serum creatinine level: <= 1.5-fold the ULN
-Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): <= 2.5-fold the ULN
6) Those who are expected to survive for >=3 months on obtaining informed consent.
7) Written informed consent regarding participation in this clinical study could be obtained from subjects and/or representatives.
1) Patients diagnosed with primary ALCL of the skin as the latest diagnosis (those with infiltration in other organs and an sALCL-like condition are regarded as eligible).
2) Those after the resection of all lesions.
3) Those with active viral, bacterial, or fungal infection within 2 weeks before the initial administration of SGN-35.
4) Those with >=grade III heart failure (New York Heart Association (NYHA) severity classification), refractory coronary disease, arrhythmia, a left ventricular ejection fraction of <50%, angina pectoris, or acute ischemia or active conduction disorder on electrocardiography, or those with a history of myocardial infarction within 6 months before the initial administration of SGN-35.
5) Those with refractory diabetes.
6) Those with a history of other malignant tumors persisting for >= 3 years and complications. However, the following cancers are excluded:
-Completely resected non-melanoma skin cancer
-Completely resected intraepithelial carcinoma
7) Those with intra-cerebral or meningeal infiltration.
8) Those with signs or symptoms suggesting progressive multifocal leukoencephalopathy (PML).
9) Those with a history of severe hypersensitivity or allergy.
10) Human immunodeficiency virus (HIV) antibody-, hepatitis B virus surface antigen (HBs antigen)-, hepatitis B virus surface antigen antibody (HBs antibody)-, hepatitis B virus core antigen antibody (HBc antibody)-, or hepatitis C virus (HCV) antibody-positive patients on a screening test. However, patients with a history of hepatitis B vaccination who are positive for HBs antibody alone will not be excluded.
11) Patients with liver cirrhosis.
12) Those in whom autologous stem cell transplantation (ASCT) was performed within 12 weeks before the initial administration of SGN-35.
13) Those in whom homologous stem cell transplantation was performed.
14) Those who received treatment for malignant tumors (radiotherapy, chemotherapy, and hormonal therapy) within 2 weeks before the initial administration of SGN-35. However, those who received biological preparations in a longer period: either 6 weeks before the initial administration of this drug or a period corresponding to 5-fold the half-life, will be excluded.
15) Those who received the systemic administration of adrenocorticohormones at a non-steady dose within 1 week before the initial administration of SGN-35.
16) Those who took drugs that inhibit CYP3A4 (clarithromycin, itraconazole, verapamil, and diltiazem) or ingested foods/supplements (such as grapefruit) within 1 week before the initial administration of SGN-35.
17) Those who took drugs that induce CYP3A4 (phenytoin, phenobarbital, rifampicin, carbamazepine) or ingested foods/supplements (such as St. John's wort) within 2 weeks before the initial administration of SGN-35.
18) Those to whom other investigational drugs were administered within 4 weeks before the initial administration of SGN-35.
19) Those in whom medical instruments under a clinical study were used within 4 weeks before the initial administration of SGN-35.
20) Those with hypersensitivity to additives contained in the composition of SGN-35.
21) Pregnant (human chorionic gonadotropin-positive) or lactating patients.
22) Those who are not willing to conduct appropriate contraception from informed consent acquisition until 6 months after the final administration of the investigational drug.
23) Those with positive reactions on a pregnancy test at the time of screening or on Day 1 of Cycle
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Dose-limiting toxicity (DLT)<br>2) Adverse events
- Secondary Outcome Measures
Name Time Method 1)Pharmacokinetics (serum concentration of SGN-35, plasma concentration of monomethylauristatin E (MMAE), and serum concentrations of all antibodies)<br>2)Response rate (ORR), complete remission rate, response period, progression-free survival (PFS), event-free survival (EFS)